Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Synchrony in the Post-operative Patient (SYNCHRONY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01771341
First received: June 15, 2012
Last updated: January 21, 2015
Last verified: January 2015
  Purpose

Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.

This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.


Condition Intervention
Patient-ventilator Asynchronism
Device: MAQUET SERVOi ventilator with Edi Catheter
Device: MAQUET SERVOi ventilator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Synchrony in the Post-operative Patient (NAVA vs Pressure Support)

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Asynchrony index (AI) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Number of asynchrony events/total respiratory rate


Secondary Outcome Measures:
  • PaO2/FiO2 ratio [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    ratio of partial pressure arterial oxygen and fraction of inspired oxygen


Enrollment: 29
Study Start Date: February 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Pressure support Device: MAQUET SERVOi ventilator
Pressure Support
Other Name: Pressure Support
Experimental: NAVA Device: MAQUET SERVOi ventilator with Edi Catheter
NAVA respiratory modality
Other Name: Neurally Adjusted Ventilatory Assist

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult > 18 yr-old
  • abdominal post-operative patient
  • able to trigger the ventilator

Exclusion Criteria:

  • infant
  • pregnancy
  • esophageal surgery
  • recent esophageal variceal bleeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771341

Locations
France
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
Pierre Bénite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Florent WALLET, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01771341     History of Changes
Other Study ID Numbers: 2010.646
Study First Received: June 15, 2012
Last Updated: January 21, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
NAVA
post operative

ClinicalTrials.gov processed this record on March 03, 2015